Key Responsibilities:
- Lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities.
- Lead facilitate and participate in technical discussions to successfully resolve problems with equipment suppliers methods project issues and deviations.
- Design develop and deploy automation within manufacturing unit operations to ensure competitiveness and organizational excellence.
- Progress the technical understanding of process impact on drug product ensuring consistent scientific excellence and scientific quality standards are met.
- Lead support and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing. Responsible for ongoing production and continuous improvement initiatives.
- Opportunity to develop process engineering skills including the use of multiphysics software for process modeling and the statistical analysis of data.
Qualifications :
Education:
- Minimum of a BS in Biomedical Engineering or relevant engineering concentration with 5 years of experience (including co-op internships or industry experience) is required. MS with 2 years of work experience is preferred.
Qualifications:
- Experience in GxP automation equipment commissioning qualifications and life-cycle management are required.
- Experience and knowledge in GxP Fill/Finish applications is required
- Proficiency in sensors and signal conditioning circuit design/analysis and automation control systems are preferred.
- Proven proficiency and experience in biologics (mAbs gene therapies cell therapies etc.) within the pharmaceutical industry with a high level of technical understanding are preferred.
- Effective communication skills by delivering information across multifunctional groups/sites and demonstrated leadership in providing integration of activities s are required.
Additional Information :
Position is full-time Monday-Friday generally 8 a.m. - 5 p.m. weekend work might be expected. Candidates currently living within a commutable distance of Malvern PA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time